FDA approves Lilly's Olumiant (baricitinib) for pediatric patients 12 years of age and older with severe alopecia areata

FDA approval supported by data from BRAVE-AA-PEDS, the first and largest Phase 3 study specifically designed to evaluate pediatric patients with severe alopecia areata (AA)

Treatment with Olumiant resulted in substantial scalp hair regrowth, as well as improvements in eyebrows and eyelashes

Severe AA can result in extensive hair loss during adolescence, a formative stage of life

INDIANAPOLIS, Sept. 25, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) approved Olumiant (baricitinib), a once-daily pill, for the treatment of pediatric patients 12 years of age and older with severe alopecia areata (AA). 1 The approval expands Olumiant's U.S. label, building on its established use in adults with moderately to severely active rheumatoid arthritis and severe AA.

AA is a chronic immune-mediated disease that causes unpredictable hair loss. As many as 2% of people develop AA at some point in their lives, 2 and nearly 40% of cases occur before the age of 20. 3 Early-onset AA can be more severe and lead to extensive hair loss. 3

"Today's approval marks an important milestone for young people living with severe alopecia areata and their families, who have had limited treatment options to date," said Adrienne Brown, executive vice president and president, Lilly Immunology. "The visible and often extensive hair loss that comes with severe alopecia areata can have a profound impact on anyone, especially adolescents who are at a pivotal stage of life. Expanding Olumiant to patients as young as 12 provides them a much-needed treatment choice and reinforces our commitment to advancing care for people living with immune-mediated diseases."

The FDA approval is based on 36-week data from the adolescent cohort (ages 12 to under 18) of BRAVE-AA-PEDS, the first and largest Phase 3 study specifically designed to evaluate pediatric patients with severe AA. 4 At baseline, the median Severity of Alopecia Tool (SALT) score was 100, indicating complete scalp hair loss, and patients had been living with AA for a mean of 6.4 years. 1

At Week 36, treatment with once-daily Olumiant delivered: 1

The overall safety profile observed in pediatric patients 12 years of age and older with severe AA is consistent with the safety profile in adults with severe AA. 1 The U.S. FDA-approved labeling for Olumiant includes a boxed warning for risk of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE) and thrombosis. 1 See below for full Safety Summary.

"Severe alopecia areata that starts early in life can be more extensive and harder to treat over time, making it important to consider all available treatment options early in the course of disease," said Brittany Craiglow, M.D., adjunct associate professor of dermatology, Yale School of Medicine. "The evidence supporting Olumiant's approval is particularly meaningful because it comes from a Phase 3 study specifically designed for pediatric patients, helping clinicians and families make more informed decisions when considering advanced therapies."

Olumiant is available as 4 mg, 2 mg and 1 mg tablets. 1 The recommended dose is Olumiant 2 mg/day, with an increase to 4 mg/day if treatment response is inadequate. 1 For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider treating with 4 mg/day. Once an adequate response is achieved on 4 mg/day, the dosage is to be decreased to 2 mg/day. 1

"Alopecia areata can affect much more than hair, particularly during adolescence, when young people are navigating important personal and social milestones," said George Gondo, chief mission officer, National Alopecia Areata Foundation. "More treatment choices mean more families have the opportunity to find the option that's right for their child, together with their doctor."

Lilly is committed to ensuring patients have access to much-needed medicines. Today, Olumiant has coverage at three of the largest pharmacy benefit managers (PBMs) for adults with severe AA. 5 Through Lilly Support Services™ for Olumiant, Lilly offers a patient support program including co-pay assistance for eligible, commercially insured patients.

Learn more about Olumiant; view the 2 mg and 4 mg product photos and brand logo.

Since 2017, more than 33,000 patients have been prescribed Olumiant in the U.S. 6 Olumiant is a once-daily, oral JAK inhibitor discovered by Incyte and licensed to Lilly and is available through specialty pharmacies nationwide. In 2022, the FDA approved Olumiant for adult patients with severe AA, making it the first systemic treatment approved in the U.S. for this condition. In April 2026, the European Commission also approved Olumiant for the treatment of adolescents (ages 12 to under 18) with severe AA.

About BRAVE-AA-PEDS

BRAVE-AA-PEDS (NCT05723198) is an ongoing, placebo-controlled, Phase 3 clinical trial involving pediatric patients ages 12 to under 18 years with severe AA, as measured by a SALT score of ≥50 (i.e., who had ≥50% scalp hair loss) and a current episode of severe AA lasting at least six months but no more than eight years.

The first two cohorts of patients enrolled in BRAVE-AA-PEDS included adolescents (ages 12 to under 18 years, weighing ≥ 30 kg). The first cohort included 257 adolescent participants who were randomized in a 1:1:1 ratio to receive once-daily placebo, Olumiant 4 mg or Olumiant 2 mg. The primary endpoint of this study was a SALT score ≤20 (i.e., 80% or more scalp hair coverage) at Week 36. The second cohort of 166 adolescents was randomized 1:1 to Olumiant 4 mg or Olumiant 2 mg to further accumulate safety data. 7

About Olumiant

Olumiant, a once-daily, oral JAK inhibitor, was discovered by Incyte and licensed to Lilly. Baricitinib is approved in the U.S. and more than 75 countries as a treatment for adults with moderately to severely active rheumatoid arthritis. Olumiant is also approved for adults and pediatric patients 12 years of age and older with severe AA in the US, European Union and Japan. Olumiant is also approved for the treatment of hospitalized adults with COVID-19 in the U.S.

The U.S. FDA-approved labeling for Olumiant includes a Boxed Warning for Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events and Thrombosis. See the full Prescribing Information here. 1

In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of Olumiant and certain follow-on compounds for patients with inflammatory and autoimmune diseases.

INDICATIONS AND SAFETY SUMMARY WITH WARNINGS

Olumiant ® (O-loo-me¯ -ant) is a Janus kinase (JAK) inhibitor used to treat:

It is not known if Olumiant is safe and effective in children with juvenile idiopathic arthritis or with severe alopecia areata who are younger than 12 years old.

Warnings - Olumiant may cause serious side effects, including:

If you get a serious infection, your doctor may stop Olumiant until your infection is controlled.

Common side effects

The most common side effects of Olumiant in people treated for alopecia areata include:

The most common side effects of Olumiant in people treated for rheumatoid arthritis include:

These are not all the possible side effects of Olumiant. Tell your doctor if you have any side effects. You can report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using

Before you use Olumiant, tell your doctor if you:

❑ Are being treated for an infection, have an infection that won't go away or keeps coming back, or think you have symptoms of an infection.

❑ Have TB or have been in close contact with someone with TB.

❑ Have or had shingles (herpes zoster).

❑ Have or had hepatitis B or C, cancer, or blood clots in the veins of your legs or lungs.

❑ Live, have lived, or have visited parts of the country that increase your risk of fungal infections. These may include the Ohio and Mississippi River valleys and the Southwest. Ask your doctor if you do not know if you have lived in an area where these infections are common.

❑ Are a current or past smoker.

❑ Have or had a heart attack, other heart problems or stroke.

❑ Have other medical conditions, including kidney or liver problems, low blood cell counts, diabetes, lung disease, HIV, or a weak immune system.

❑ Have any stomach-area pain or have been diagnosed with inflammation in the large intestine (diverticulitis) or ulcers in your stomach or intestines.

❑ Have recently received or plan to receive a vaccine. People taking Olumiant should not receive live vaccines.

❑ Are pregnant or plan to become pregnant. It is not known if Olumiant may harm your unborn baby. There is a pregnancy exposure registry that monitors women exposed to Olumiant during pregnancy. If you become pregnant during treatment with Olumiant call 1‑800‑284-1695 or visit https://pregnancyregistry.lilly.com to report the pregnancy.

❑ Are breastfeeding or plan to breastfeed. You should not breastfeed while taking Olumiant and for 4 days after the last dose. Talk to your doctor about the best way to feed your baby while taking Olumiant.

❑ Are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. It is especially important to tell your doctor, if you take:

❑ Are under age 18. It is not known if Olumiant is safe and effective in children for conditions other than alopecia areata or in children under 12 years of age.

How to take

Learn more

Olumiant is a prescription medicine. For more information, call 1-800-545-5979 or go to www.olumiant.com.

This summary provides basic information about Olumiant but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Olumiant and how to take it. Your doctor is the best person to help you decide if Olumiant is right for you.

BA CON BS SEP2026

About Lilly

Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit  Lilly.com and  Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY

Trademarks and Trade Names

All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

About Incyte

Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Olumiant (baricitinib) as a treatment for alopecia areata and reflects Lilly's and Incyte's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there can be no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with the results to date, and that Olumiant will receive additional regulatory approvals, or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's and Incyte's most recent respective Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly and Incyte undertake no duty to update forward-looking statements to reflect events after the date of this release.

References

1 Olumiant. Prescribing Information. Lilly USA, LLC.

2 Mirzoyev SA, Schrum AG, Davis MDP, Torgerson RR. Lifetime incidence risk of alopecia areata estimated at 2.1% by Rochester Epidemiology Project, 1990-2009. J Invest Dermatol. 2014;134(4):1141-1142. doi:10.1038/jid.2013.464

3 Villasante Fricke, A. C., & Miteva, M. (2015). Epidemiology and burden of alopecia areata: a systematic review. Clinical, cosmetic and investigational dermatology, 8, 397–403. https://doi.org/10.2147/CCID.S53985

4 Passeron T, et al. Baricitinib provides significant hair regrowth in adolescents with severe alopecia areata: 36-week efficacy and safety results from a Phase 3 randomized, controlled trial. American Academy of Dermatology Annual Meeting. March 7-11, 2025.

5 Eli Lilly and Company. (2026, June 9). FDA approves Lilly's EBGLYSS ® (lebrikizumab-lbkz) for one maintenance dose every eight weeks in patients with moderate-to-severe atopic dermatitis [Press release]. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-ebglyssr-lebrikizumab-lbkz-one-maintenance

6 Enterprise Longitudinal Access and Adjudication Dataset (ELAAD) - September 2026.

7Craiglow B, Piraccini BM, Ohyama M, et al. Impact of severity and disease course on baricitinib treatment response in adolescents with severe AA: updated data from the BRAVE-AA-PEDS trial. Presented at: Society for Pediatric Dermatology Annual Meeting; July 22-25, 2026; Minneapolis, MN.

Olumiant ® and Lilly Support Services™ are trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

CMAT-51507 09/2026 © Lilly USA, LLC 2026. All rights reserved.

Refer to:

Kelly Hoffman; [email protected] (Media)

Michael Czapar; [email protected] (Investors)

SOURCE Eli Lilly and Company